CSL registers CSL-sponsored interventional studies on ICMJE-recognized public registries before enrolment of the first participant.
CSL-sponsored observational (non-interventional) studies are registered according to applicable local requirements and standards.
Conducting Research & Clinical Trials
A clinical trial is a research study in which people volunteer to receive a medical treatment and to be observed for its effects, both in terms of its safety and its effectiveness. Before a clinical trial can begin, the experimental product is first tested extensively in the laboratory and where necessary, in animals. Clinical trials are carefully supervised, monitored, and documented. The applicable regulatory authority must grant approval to conduct testing in humans, and clinical trials are overseen by an independent review or ethics committee.
CSL conducts clinical trials in accordance with our Code of Responsible Business Practice and the current Guideline for Good Clinical Practice (GCP) of the International Conference on Harmonization (ICH). GCP is an international ethical and scientific quality standard for designing, conducting and reporting studies that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of study subjects are protected and that the clinical trial data are credible. It also ensures that CSL conducts clinical trials consistent with the principles specified in the Declaration of Helsinki (a set of ethical principles regarding human experimentation developed by the World Medical Association and originally adopted in 1964).
CSL’s Quality Management System consists of an independent Quality Assurance function along with a Quality Operations group that is a part of the Clinical development organisation. Together, the two groups provide the foundation for a risk-based, proactively managed Quality System across Global Clinical development that ensures regulated clinical trial activities are:
- Conducted with a high level of quality;
- Conducted according to regulatory requirements;
- Consistent with industry best practices;
These objectives are achieved through:
- Maintenance of a robust set of written standard operating procedures (SOPs) with staff adequately trained against them;
- A compliance monitoring program to ensure adherence to the SOPs and drive inspection readiness;
- A well-defined Corrective Action/Preventive Action (CAPA) management process that promotes a systematic approach to dealing with critical/major issues and enabling study teams to effectively apply real-time lessons learned; Execution of audits on our investigative sites, vendors, and internal processes/systems.
Clinical Trial Disclosure and Transparency
CSL recognizes that there are important public health benefits associated with making clinical trial information widely available to practicing physicians, patients and patient associations.
CSL has established policies and procedures aligned with the PhRMA/EFPIA Principles for Responsible Clinical Trial Data sharing.
We support policies and actions that seek to appropriately enhance the exchange of scientific information in addition to complying with applicable national and international laws and regulations relevant to clinical trial disclosure and data privacy.
CSL has a team focused on timely registration of CSL-sponsored clinical trials, publication of clinical study results, sharing of layperson summaries, supporting the release of clinical documents by health authorities, and sharing of individual (anonymized) patient data. See below for how we do this.